Fatigue Reduction and Quality of Life Enhancement
Following Therapy with Taurox

Objective

Taurox
has been reported to reduce fatigue in patients with HCV, cancer,
Post-Lyme/Chronic Lyme Disease, CFS and Fibromyalgia. Clinical trials
demonstrated improvement in QOL measures in addition to a reduction in
fatigue. However, clinical trials often report better results than
post-marketing studies. We studied QOL benefit in home use, in a
generally healthier population not subject to clinical trial selection
and the attendant healing environment.

Materials and methods

Taurox
(Tauroxicum) is a homeopathic remedy ingredient made from COBAT, a
modified di-peptide containing ß-alanine and taurine. Taurox is
administered in nanogram/day doses sub-lingually. Attempts were made to
contact all persons purchasing Taurox products from CureImmune, Inc. If
the customer was there, a structured interview was conducted. In order
to avoid reply selection bias, no message was left for customers who
were not available.

Results

A total of 76
users were reached in three calling periods. Some QOL measures did not
change, while other specific measures of QOL were reported to be
significantly improved. Fatigue was decreased in over 70% of users;
other CNS symptoms (mood and ability to concentrate) and allergy
symptoms improved in 40-70% of users.

Human Clinical Outcome Studies:
Physician office based open label clinical outcomes studies were
undertaken to evaluate fatigue and other symptoms. The table shows
fatigue scores as assessed after 3-6 weeks of Taurox by the FACIT-F
(3,4) validated scale. Frequency of allergies and other symptoms were
also reported. Further improvement with time was seen

METHODS

A
structured interview was conducted with all customers reached who had
been taking any Taurox containing product (note C). For each specific
symptom, they were asked to categorize their response (columns in the
table). Several attempts were made to contact all persons purchasing
Taurox products from CureImmune, Inc. In order to avoid reply selection
bias, no message was left for customers who were not available. Taurox
is administered sublingually in preparations containing from 3X to 30X
potencies of Taurox. In total, approximately 15 to 300 nanogram/day of
Taurox were received by compliant users. Each preparation contained
both molecular and sub molecular potencies of Taurox and of other
homeopathic remedies (note C).

As blinding and placebo
controls are not possible in post marketing studies internal control
questions were included. Users were asked about appetite/eating, which
were previously believed to not be affected by Taurox. In addition
users were asked about a change in “cravings” (cigarettes, etc.) At the
time the study was done, the interviewers thought that people often
experienced such a decrease.

Pre-Market Clinical Studies

Indication

N

Mean improvementOf responders

% Improved

Pre- vs Post T-test (2-tailed)

Fatigue (total)

30

49%

73%

P=0.001

in HCV

8

51%

87.5%

n/a (small subset of above)

in Cancer

11

55%

73%

n/a (subset)

in CFS

3

37%

100%

n/a (subset)

in Allergies

20

47%

65%

P=0.038 (subset)

Allergies

20

64%

60%

P=0.027

RESULTS

A
total of 76 customers were reached in three calling periods covering a
1 year period. Some QOL measures did not change. Less than 7% of the
people reported a definite decrease in the symptoms of appetite/eating
or cravings. In comparison several specific measures of QOL were
reported to be significantly improved. Approximately 76% reported an
improvement in energy/fatigue. [This includes people reporting that it
was either “definitely beneficial” (71%) or “maybe” beneficial (5%)].
Other CNS symptoms, including a “feeling of well being” (74%), ability
to concentrate/think (66%) and/or sleep (34%) were also frequently
improved. Those people with allergies frequently thought they were or
might be experiencing some benefit in the allergic (rhinitis or
asthmatic) symptoms (41%). See following table for delineation of
symptoms asked about (rows) allowed responses (columns) and percentage
of users with each responses. No significant adverse events were noted.
Transient headaches, excitement, anxiousness and rarely increased
intensity of frequency of heartbeat were reported early in therapy. In
some cases this led to usually transient dose reduction. One person
reported being over-energized and not sleeping as well, he typically
took the product late in the day (contrary to the instructions).

DISCUSSION

Fatigue
is the most frequent complaint in most medical practices; 30-50% of the
U.S. population experiences fatigue (5). Fatigue significantly
decreases QOL in most all persons with chronic disease. Treatment of
anaemia may relieve fatigue, however treatment with erythropoietin
(EPO) may accelerate the growth of some cancers and have potentially
fatal side effects (6). EPO gives on average a less than 5 point
overall improvement in the FACIT-F (0-53 point) fatigue score (7) while
Taurox provided on average a 12 point improvement in the score in pre
market clinical studies (described above). An improvement of 3-5 points
is considered to be clinically meaningful (4, 7, 8).

The
clinical trial healing environment and patient selection bias often
lead to greater apparent therapeutic benefit in clinical trials than is
observed in the subsequent post marketing use of a drug. However Taurox
benefit occurs independent of physician influence. A number of other
facts also suggest that the reduction in fatigue seen is not due to
placebo or bias. Based on previous anecdotal reports, the interviewers
believed there would be a change in cravings. Both the user and
interviewer bias would be to expect a decrease in stimulant use,
however little benefit was reported in these areas. In studies of
fatigue, reduction by EPO injections were not sufficient to cause a
decrease in fatigue, only subjects with the largest increase in Hg
reported fatigue reduction (8). The CFS literature indicates that
placebo effect (and the effect of most tested therapies) is between 0
and 25% (9). Thus both internal test questions and the scientific
literature suggest that the level of fatigue reduction in this study
cannot be accounted for by placebo effect.

CONCLUSIONS

Taurox
produces similar beneficial effects in the home environment, as in
studies associated with the physician office healing environment .
Taurox improves several CNS related symptoms. Fatigue was the most
frequently improved symptom. Participants also reported an improved
“feeling of well being” and improved “concentration/ability to think”.

A.
Safety of Taurox was assessed in 4 rodent studies, 2 dosed by IV
injection (single dose studies), and 2 dosed by oral gavage (multiple
dose studies). Taurox did not produce any gross signs of toxicity when
administered by oral gavage to rats for 14 days at a dose of 2,000
mg/kg/day. Due to the low dose required for effectiveness in
humans, this represents a safety factor > ten million or 107.

B Details of the proving and the Materia Medica will be presented separately.

C. Ingredients in each product. More
details available on the web site. Percentage of sample
population using each product is indicated. Some used more than
one product.